Catheter pump

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

0001Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application, including U.S. patent application Ser. No. 13/801,528 (now issued as U.S. Pat. No. 9,358,329), filed Mar. 13, 2013, entitled Catheter Pump, and U.S. Application No. 61/667,903 filed Jul. 3, 2012, entitled Catheter Pump, are hereby incorporated by reference under 37 CFR 1.57.

BACKGROUND OF THE INVENTION

0002Field of the Invention

0003This application is directed to a catheter pump for mechanical circulatory support of a heart.

0004Description of the Related Art

0005Heart disease is a major health problem that has high mortality rate. After a heart attack, only a small number of patients can be treated with medicines or other non-invasive treatment. However, a significant number of patients can recover from a heart attack or cardiogenic shock if provided with mechanical circulatory support.

0006In a conventional approach, a blood pump having a fixed cross-section is surgically inserted between the left ventricle and the aortic arch to assist the pumping function of the heart. Other known applications involve providing for pumping venous blood from the right ventricle to the pulmonary artery for support of the right side of the heart. The object of the surgically inserted pump is to reduce the load on the heart muscle for a period of time, to stabilize the patient prior to heart transplant or for continuing support. Surgical insertion, however, can cause additional serious stresses in heart failure patients.

0007Percutaneous insertion of a left ventricular assist device (“LVAD”), a right ventricular assist device (“RVAD”) or in some cases a system for both sides of the heart (sometimes called biVAD) therefore is desired. Conventional fixed cross-section ventricular assist devices designed to provide near full heart flow rate are too large to be advanced percutaneously, e.g., through the femoral artery.

0008There is a continuing need for improved cannula that provide sufficient expansion force and a stable expanded shape while still allowing for reliable and easy collapse to a delivery size. In other words, the cannula should have sufficient force to expand, but also be collapsible under significant sheathing force while avoiding a risk of damaging the cannula during re-sheathing. There is a continuing need for improved cannula that can be expanded and collapsed, in some cases over many cycles, without risking breakage of the struts and connectors forming the mesh. Broken struts pose a risk of complicating patient treatment and/or compromising the performance of the device.

SUMMARY OF THE INVENTION

0009There is an urgent need for a pumping device that can be inserted percutaneously and also provide full cardiac rate flows of the left, right, or both the left and right sides of the heart when called for.

0010In one embodiment, an apparatus is provided for inducing motion of a fluid relative to the apparatus. The apparatus can be a catheter pump, as discussed below. The apparatus can include a rotatable impeller and an elongate cannula. The cannula has a plurality of circumferential members and a plurality of circumferential connectors. The circumferential members are disposed about a space, e.g., a volume including at least the impeller zone. One or more of, e.g., each of, the circumferential members can have an undulating configuration including a plurality of apices connected by elongate struts. The circumferential connectors can be disposed between alternating struts of adjacent circumferential members. A plurality of axial connectors is disposed between a proximal side of a proximal apex and a distal side of an adjacent circumferential member in the impeller zone of cannula.

0011In some embodiments, the cannnula is differentiated along its length to have varying stiffness. The elongate cannula has an impeller zone disposed about the impeller and a distal zone disposed distal of the impeller zone. The distal zone can be made more flexible by reducing the number of connectors disposed therein. For example, the impeller zone can have alternating elongate struts that are connected by circumferential connectors and the distal zone can have alternating elongate struts that are free of such connections.

0012In one variation, each of the connectors of the plurality has a distal end coupled with a proximal side of a proximal apex of a first circumferential member, a proximal end coupled with a distal face of a second circumferential member disposed adjacent to and proximal of the first circumferential member. Each of the connectors has an arcuate section disposed between the proximal and distal ends. In this variation, the arcuate section comprises a single convex portion disposed between the proximal and distal ends.

0013A first plurality of axial connectors is disposed between a proximal side of a proximal apex and a distal side of an adjacent circumferential member in the impeller zone of the cannula. A second plurality of axial connectors is disposed between a proximal side of a proximal apex and a distal side of an adjacent circumferential member in the distal zone of the cannula.

0014In another embodiment, an apparatus for pumping blood includes a rotatable impeller, an elongate cannula, and a sheath configured to be positioned over the elongate cannula. The elongate cannula has a plurality of circumferential members disposed about the impeller. One or more of, e.g., each of, the circumferential members can have an undulating configuration. The undulating configuration can include a plurality of proximal and distal apices, with proximal apices connected to distal apices by an elongate strut. The sheath is configured to be positioned over the elongate cannula to actuate the cannula from an expanded configuration to a collapsed configuration. The elongate cannula is configured to deflect radially inwardly in an area around the proximal apices before the apices move into the sheath.

0015In some configurations, the elongate cannula has an impeller zone disposed about the impeller and a distal zone disposed distal of the impeller zone. For example, the impeller can extend in about one-half or less of the length of the cannula. The distal zone may be more easily compressed by the sheath because the impeller is not present in that area. As a result, the cannula can have a different configuration in the distal zone.

0016In another configuration, a catheter pump is provided. A catheter pump is an example of an apparatus for inducing motion of a fluid relative to the apparatus. The catheter pump includes a rotatable impeller and an elongate cannula having a mesh comprising a plurality of circumferential members disposed about the impeller. The mesh also has a plurality of axial connectors extending between a proximal side of a distal circumferential member and a distal side of a proximal circumferential member. The circumferential members are radially self-expandable. A sheath is configured to be positioned over the elongated cannula to actuate the cannula from an expanded configuration to a collapsed configuration. The cannula is configured to minimize a risk of fracture within the mesh, e.g., of the axial connectors, as the elongated cannula moves into the sheath.

0017In a further embodiment, an apparatus for inducing motion of a fluid relative to the apparatus is provided. The apparatus includes a rotatable impeller and an elongate cannula. The elongate cannula is defines a blood flow channel in which the impeller is disposed. The cannula has an expandable structure comprising that has a plurality of circumferential members, a plurality of circumferential connectors, and a plurality of axial connectors. The circumferential members are disposed about the blood flow channel. The circumferential members have an undulating configuration including a plurality of apices connected by elongate struts. The circumferential connectors are disposed between alternating struts of adjacent circumferential members. The axial connectors have a distal end coupled with a proximal side of a proximal apex of a first circumferential member, a proximal end coupled with a distal face (e.g., an edge) of a second circumferential member disposed adjacent to and proximal of the first circumferential member. The axial connectors have an arcuate section disposed between the proximal and distal ends. The arcuate section comprises a single convex portion disposed between the proximal and distal ends.

0018In another embodiment, an apparatus for pumping blood is provided that includes a rotatable impeller, an elongate cannula, and an axial member. The elongate cannula has a plurality of circumferential members disposed about the impeller. One or more of the circumferential members has an undulating configuration including a plurality of proximal and distal apices. Each proximal apex is connected to a distal apex by an elongate strut. The axial member has a distal end coupled with a proximal apex of a first circumferential member a proximal end coupled with a second circumferential member disposed proximal of the first circumferential member. The axial member has a length that is less than the distance between the proximal apex to which the distal end of the axial member is connected and a proximal apex of the second circumferential member that is axially aligned with the proximal apex to which the distal end of the axial member is connected.

0019In another embodiment, a catheter pump is provided that includes a rotatable impeller and an elongate cannula. The elongate cannula has a mesh that has a plurality of circumferential members disposed about the impeller. The elongate cannula has a plurality of axial connector extending between a proximal side of a distal circumferential member and a distal side of a proximal circumferential member. The circumferential members are radially self-expandable. The cannula is configured to minimize fracture within at least in the distal zone of the mesh as the elongated cannula moves into a sheathing device.

0020In another embodiment, a cannula for conveying blood is provided that includes an in-situ expandable and collapsible mesh structure and a polymeric enclosure. The in-situ expandable and collapsible mesh structure has a plurality of undulating circumferential members surrounding a lumen. Each circumferential member has proximal and distal vertices. The polymeric enclosure is disposed about the mesh structure to enclose the lumen along a length between an inlet and an outlet. The number of proximal vertices in an area defined between a proximal circumference intersecting the proximal vertex of a circumferential member and a distal circumference intersecting the distal vertex of the same circumferential member adjacent to the proximal vertex is at least two.

BRIEF DESCRIPTION OF THE DRAWINGS

0021A more complete appreciation of the subject matter of this application and the various advantages thereof can be realized by reference to the following detailed description, in which reference is made to the accompanying drawings in which:

0022<figref idref="DRAWINGS">FIG. 1</figref> illustrates one embodiment of a catheter pump configured for percutaneous application and operation;

0023<figref idref="DRAWINGS">FIG. 2</figref> is a plan view of one embodiment of a catheter assembly adapted to be used with the catheter pump of <figref idref="DRAWINGS">FIG. 1</figref>;

0024<figref idref="DRAWINGS">FIG. 3</figref> show a distal portion of the catheter assembly of similar to that of <figref idref="DRAWINGS">FIG. 2</figref> in position within the anatomy;

0025<figref idref="DRAWINGS">FIG. 4</figref> illustrates a wall pattern of a mesh structure in a flat configuration, where the mesh structure is configured to provide enhanced flexibility in a distal zone;

0026<figref idref="DRAWINGS">FIG. 4A</figref> is a detail view of a distal portion of the wall pattern of <figref idref="DRAWINGS">FIG. 4</figref>;

0027<figref idref="DRAWINGS">FIG. 5</figref> shows a formed mesh structure for a cannula having a wall pattern similar to that of <figref idref="DRAWINGS">FIG. 4</figref>;

0028<figref idref="DRAWINGS">FIG. 5A</figref> is a detail view of the distal portion of the formed mesh structure of <figref idref="DRAWINGS">FIG. 5</figref>;

0029<figref idref="DRAWINGS">FIG. 6</figref> illustrates another wall pattern of a mesh structure in a flat configuration, where the mesh structure is configured to minimize fracture risk;

0030<figref idref="DRAWINGS">FIG. 6A</figref> is a detail view of a distal portion of the wall pattern of <figref idref="DRAWINGS">FIG. 6</figref>;

0031<figref idref="DRAWINGS">FIG. 7</figref> shows a cannula including a formed mesh structure having the wall pattern similar to that of <figref idref="DRAWINGS">FIG. 6</figref> covered with a film layer;

0032<figref idref="DRAWINGS">FIG. 7A</figref> is a detail view of a distal portion of the cannula of <figref idref="DRAWINGS">FIG. 7</figref>;

0033<figref idref="DRAWINGS">FIG. 8</figref> illustrates another wall pattern of a mesh structure in a flat configuration, where the mesh structure is configured to provide enhanced flexibility in a distal zone, while minimizing fracture risk;

0034<figref idref="DRAWINGS">FIG. 9</figref> shows a formed mesh structure for a cannula having the wall pattern of <figref idref="DRAWINGS">FIG. 8</figref>;

0035<figref idref="DRAWINGS">FIG. 10</figref> illustrates another wall pattern of a mesh structure in a flat configuration, where the mesh structure is configured to provide enhanced flexibility in a distal zone, while minimizing fracture risk;

0036<figref idref="DRAWINGS">FIG. 11</figref> shows a formed mesh structure for a cannula having the wall pattern of <figref idref="DRAWINGS">FIG. 10</figref>;

0037<figref idref="DRAWINGS">FIG. 12</figref> is a detail view of a distal portion of the wall pattern of <figref idref="DRAWINGS">FIGS. 8 and 10</figref>;

0038<figref idref="DRAWINGS">FIG. 13</figref> is a detail view of a first variation of the distal portion of the formed mesh structure of <figref idref="DRAWINGS">FIG. 12</figref>;

0039<figref idref="DRAWINGS">FIG. 14</figref> is a detail view of a second variation of the distal portion of the formed mesh structure of <figref idref="DRAWINGS">FIG. 12</figref>;

0040<figref idref="DRAWINGS">FIG. 14A-1</figref> is a detail view of a proximal portion of another variation of a wall pattern that is stable and minimizes fracture;

0041<figref idref="DRAWINGS">FIG. 14A-2</figref> is a detail view of a central portion of the wall pattern for which the proximal portion is shown in <figref idref="DRAWINGS">FIG. 14A-1</figref>

0042<figref idref="DRAWINGS">FIG. 14A-3</figref> is a detail view of a distal portion of the wall pattern for which the proximal portion is shown in <figref idref="DRAWINGS">FIG. 14A-1</figref>

0043<figref idref="DRAWINGS">FIG. 15</figref> illustrates another wall pattern of a mesh structure in a flat configuration, where the mesh structure is configured to provide more ports for blood to flow into or out of a cannula formed with this pattern;

0044<figref idref="DRAWINGS">FIG. 15A</figref> is a detail view of a proximal portion of the pattern of <figref idref="DRAWINGS">FIG. 15</figref>;

0045<figref idref="DRAWINGS">FIG. 16</figref> is an expanded view of the pattern of <figref idref="DRAWINGS">FIGS. 15-15A</figref>; and

0046<figref idref="DRAWINGS">FIG. 17</figref> is a graph of the sheathing force for collapsing a cannula and an impeller for an example wall pattern.

0047More detailed descriptions of various embodiments of components for heart pumps useful to treat patients experiencing cardiac stress, including acute heart failure, are set forth below.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

0048This application is directed to apparatuses for inducing motion of a fluid relative to the apparatus. The apparatus can be a catheter pump, e.g., a percutaneous heart pump.

0049<figref idref="DRAWINGS">FIGS. 1 and 2</figref> illustrate various features of a catheter pump <b>10</b>. The catheter pump <b>10</b> can provide high performance including flow rates similar to full cardiac output. The pump <b>10</b> includes a motor driven by a controller <b>22</b>. The controller <b>22</b> directs the operation of the motor <b>14</b> and an infusion system <b>26</b> that supplies a flow of infusate in the pump <b>10</b>. A catheter system <b>80</b> that can be coupled with the motor <b>14</b> houses an impeller within a distal portion thereof. In various embodiments, the impeller is rotated remotely by the motor <b>14</b> when the pump <b>10</b> is operating. For example, the motor <b>14</b> can be disposed outside the patient. In some embodiments, the motor <b>14</b> is separate from the controller <b>22</b>, e.g., to be placed closer to the patient. In other embodiments, the motor <b>14</b> is part of the controller <b>22</b>. In still other embodiments, the motor is miniaturized to be insertable into the patient. Such embodiments allow the drive shaft to be much shorter, e.g., shorter than the distance from the aortic valve to the aortic arch (about 5 cm or less). Some examples of miniaturized motors catheter pumps and related components and methods are discussed in U.S. Pat. No. 5,964,694; U.S. Pat. No. 6,007,478; U.S. Pat. No. 6,178,922; and U.S. Pat. No. 6,176,848, all of which are hereby incorporated by reference herein in their entirety for all purposes.

0050<figref idref="DRAWINGS">FIG. 3</figref> illustrates one use of the catheter pump <b>10</b>. A distal portion of the pump <b>10</b> is placed in the left ventricle LV of the heart to pump blood from the LV into the aorta. The pump <b>10</b> can be used in this way to treat patients with a wide range of conditions, including cardiogenic shock, myocardial infarction, and acutely decompensated heart failure, and also to support a patient during a procedure such as percutaneous coronary intervention. One convenient manner of placement of the distal portion of the pump <b>10</b> in the heart is by percutaneous access and delivery using the Seldinger technique or other methods familiar to cardiologists. These approaches enable the pump <b>10</b> to be used in emergency medicine, a catheter lab and in other non-surgical settings. Modifications can also enable the pump <b>10</b> to support the right side of the heart. Example modifications that could be used for right side support include providing delivery features and/or shaping a distal portion that is to be placed through at least one heart valve from the venous side, such as is discussed in U.S. Pat. No. 6,544,216; U.S. Pat. No. 7,070,555; and US 2012-0203056A1 (now issued as U.S. Pat. No. 8,992,406), all of which are hereby incorporated by reference herein in their entirety for all purposes.

0051<figref idref="DRAWINGS">FIG. 2</figref> shows features that facilitate small blood vessel percutaneous delivery and high performance up to and in some cases exceeding normal cardiac output in all phases of the cardiac cycle. In particular, the catheter system <b>80</b> includes a catheter body <b>84</b> and a sheath assembly <b>88</b>. An impeller assembly <b>92</b> is coupled with the distal end of the catheter body <b>84</b>. The impeller assembly <b>92</b> is expandable and collapsible. In the collapsed state, the distal end of the catheter system <b>80</b> can be advanced to the heart. In the expanded state the impeller assembly <b>92</b> is able to pump blood at relatively high flow rates. <figref idref="DRAWINGS">FIGS. 2 and 3</figref> illustrate the expanded state. The collapsed state can be provided by advancing a distal end <b>94</b> of an elongate body <b>96</b> distally over the impeller assembly <b>92</b> to cause the impeller assembly <b>92</b> to collapse. This provides an outer profile throughout the catheter assembly <b>80</b> that is of small diameter, for example 12.5 French as discussed further below.

0052Embodiments of the catheter pumps of this application can be configured with expandable structures to enhance performance. For example, an impeller for moving blood axially can be provided. The impeller can be positioned in an expandable cannula. When so positioned, the expandable cannula provides dual function of enclosing a blood flow lumen through which the impeller can act and also housing the impeller. In that sense, the cannula is also an expandable housing. The expandable cannula and impeller provide a flow rate in the pump that is much larger than would be possible using percutaneous access techniques were these components not capable of expanding. However, it may be possible to reduce flow resistance by increasing the size of a blood-flow cannula even with a fixed diameter impeller. Also, it may be possible to sequentially collapse the impeller, e.g., by withdrawing the impeller into a rigid ring or tubular segment prior to collapsing the impeller. These variant also benefit from many of the embodiments herein and are within the scope of this application even though the impeller may not be housed in the cannula at all times or at all.

0053While these configurations provide excellent flow rates, a challenge arises in collapsing the expanded structures prior to removal from the patient. The collapsing of the impeller assembly <b>92</b> is this manner is not straight-forward. In various embodiments, a mesh is used to support the expandable portion of a blood flow conduit in the impeller assembly <b>92</b>. The expandable portion can include a self-expanding structure that expands when undulating generally ring-shaped members release stored strain energy arising from circumferential compression. Compression of such a structure involves transforming axial relative movement of the sheath assembly <b>88</b> over the catheter body <b>84</b> into a circumferential compression force. There is a chance that such movement will cause the distal end to become lodged between adjacent undulating members. Such problems with compression can be more likely to occur when the undulating members are spaced apart by an axial distance that is greater than the wall thickness of the distal end of the sheath assembly <b>88</b>. While the undulating members could be moved much closer together, such an approach could make the expandable structure too stiff thereby inhibiting collapse of the expandable portion. Some embodiments herein are configured to reduce this risk, while retaining sufficient flexibility. Some embodiments are configured to prevent connectors between adjacent rings from being deformed around the distal end of the sheath assembly <b>88</b>. Various aspects of the expandable cannula and/or mesh in accordance with the invention achieve a careful balance of expansion force, collapsing force, and structural strength. <figref idref="DRAWINGS">FIGS. 4-16</figref> illustrate various embodiments of mesh structures that can be incorporated into the expandable cannula to provide advantageous performance in use.

0054Additional details of the structures disclosed in these figures, and various modified embodiments thereof, and method related to the same are discussed in U.S. application Ser. No. 13/343,617 (now issued as U.S. Pat. No. 8,485,961), filed Jan. 4, 2012, which is hereby incorporated by reference herein in its entirety. In addition, this application incorporates by reference in its entirety and for all purposes the subject matter disclosed in each of the following concurrently filed applications: application Ser. No. 13/802,556 (now issued as U.S. Pat. No. 9,446,179), entitled “DISTAL BEARING SUPPORT,” filed on the same date as this application; Application No. 61/780,656, entitled “FLUID HANDLING SYSTEM,” filed on the same date as this application; application Ser. No. 13/801,833 (now published as U.S. Patent Application Publication No. 2013/0303969), entitled “SHEATH SYSTEM FOR CATHETER PUMP,” filed on the same date as this application; application Ser. No. 13/802,570 (now issued as U.S. Pat. No. 8,721,517), entitled “IMPELLER FOR CATHETER PUMP,” filed on the same date as this application; and application Ser. No. 13/802,468 (now issued as U.S. Pat. No. 9,421,311), entitled “MOTOR ASSEMBLY FOR CATHETER PUMP,” filed on the same date as this application.

0055<figref idref="DRAWINGS">FIG. 4</figref> shows a flat wall pattern <b>200</b> of a mesh structure <b>204</b> that is configured to provide enhanced flexibility in a distal zone <b>208</b>. The distal zone <b>208</b> is disposed distally of an impeller zone <b>212</b>, which is a portion of the mesh structure <b>204</b> that is disposed around an impeller in the catheter assembly of <figref idref="DRAWINGS">FIG. 2</figref>. The impeller can be part of the impeller assembly <b>116</b>, as set forth in more detail in the U.S. application Ser. No. 13/343,617 (now issued as U.S. Pat. No. 8,485,961), incorporated by reference above. In some embodiments, the distal zone <b>208</b> and the impeller zone <b>212</b> are distinct from each other, for example having separate structure or performance characteristics. In other embodiments, the distal and impeller zones <b>208</b>, <b>212</b> are general regions of an otherwise continuous structure. In some embodiments, the distal and impeller zones overlap. The wall pattern <b>200</b> also includes distal and proximal end connection structures <b>216</b>A, <b>216</b>B, which are discussed in detail in the '617 application incorporated by reference above, and also in U.S. application Ser. No. 13/343,618 (now issued as U.S. Pat. No. 8,597,170), which is hereby incorporated by reference herein in its entirety.

0056The wall pattern <b>200</b> illustrates a plurality of circumferential members <b>224</b> and a plurality of circumferential connectors <b>228</b>. In the flat view of <figref idref="DRAWINGS">FIGS. 4 and 4A</figref>, the circumferential members <b>224</b> can be seen to extend transversely to a longitudinal axis of the pattern <b>200</b>. In the formed view of <figref idref="DRAWINGS">FIGS. 5 and 5A</figref>, these structures can be seen to extend about the circumference of the formed mesh structure <b>204</b>. As discussed below, e.g., in connection with <figref idref="DRAWINGS">FIGS. 7 and 7A</figref>, a cannula is formed by enclosing the circumferential members <b>224</b> with a polymer material, e.g., a film, to create a flow channel open on the ends but otherwise sealed to maximize axial flow through the cannula and the pump. Thus, the circumferential members <b>224</b> and later the cannula are disposed about a space, e.g., a volume including at least the impeller zone <b>212</b>.

0057In various embodiments, the polymer material is a coating disposed about the cannula mesh structure <b>204</b>. Suitable materials for the polymer coating include, but are not limited to a biocompatible polymer, a drug-eluting polymer, and a functionalized polymer such as a thromboresistant material. In various embodiments, the polymer material is Hapflex™ or Thoralon™. In the exemplary structure, the polymer material fills the voids in the mesh structure. The polymer material also coats the inner and outer walls such that the mesh structure does not come into contact with blood and tissue. In various embodiments, the polymer material is a thin coating. In various embodiments, the polymer coating has a maximum thickness of less than 10 microns, less than 9 microns, less than 8 microns, less than 7 microns, less than 6 microns, less than 5 microns, less than 4 microns, less than 3 microns, less than 2 microns, or less than 1 micron. In various embodiments, the polymer coating is formed of a plurality of layers. In various embodiments, the polymer coating is configured to reinforce the mesh structure. The polymer material may be applied by dip coating, molding, spinning on a mandrel, or other techniques. One will appreciate from the description herein that the polymer coating may be configured and applied in various other manners. Further details of suitable materials are set forth in U.S. Pat. Nos. 4,675,361 and 6,939,377, which are incorporated by reference herein in their entireties and for all purposes.

0058The circumferential members <b>224</b> preferably are configured to be self-expandable, also described as self-expanding herein. <figref idref="DRAWINGS">FIG. 4</figref> shows that in one embodiment one or more of the circumferential members <b>224</b> can have an undulating configuration. As can be seen in many of the figures, and in <figref idref="DRAWINGS">FIG. 4A</figref> specifically, circumferential members can have an alternating structure, e.g., a plurality proximal turns and distal turns connected by struts. The struts can be straight members that each have a proximal ends connected to a proximal turn and a distal end connected to a distal turn. The distal turns can be peaks and the proximal turns can be valleys, e.g., if the cannula is held with the distal end up. The distal turns can be crests and the proximal turns can be troughs, e.g., if the cannula is held with the distal end up. In some cases, the circumferential members have a generally serpentine configuration, or can be sinusoidal in nature disposed on both sides of a transverse plane. The circumferential members <b>224</b> can include a plurality of distal and proximal apices <b>232</b>A, <b>232</b>B connected by elongate struts <b>236</b>. As discussed further below, the density of the circumferential members <b>224</b> can be varied to modify the performance or the cannula.

0059The circumferential connectors <b>228</b> can be disposed between alternating struts <b>236</b> of adjacent circumferential members <b>224</b> in at least one of the distal and impeller zones <b>208</b>, <b>212</b>. For example, the connectors <b>228</b> (or other connectors discussed herein) can join a node on one circumferential member to a node on an adjacent circumferential member. In the case of the connectors <b>228</b>, the nodes are offset from the peaks and valleys. At least one of the nodes can be disposed on a strut that extends between adjacent nodes. In some cases, connectors are disposed between the crests and trough and can be disposed between a crest the a transverse mid-point of a sinusoidal circumferential member. In some patterns, the width of nodes are greater in the impeller zone than distal thereof. <figref idref="DRAWINGS">FIG. 4</figref> shows that circumferential connector <b>228</b> can be provided between opposing sides of adjacent struts <b>236</b> of at least two adjacent circumferential members <b>224</b> in the impeller zone. In one embodiment, alternating elongate struts <b>236</b> are connected to an adjacent elongate strut of an adjacent circumferential member <b>224</b>. In one embodiment, alternating elongate struts <b>236</b> are not connected to adjacent elongate struts by circumferential connectors <b>228</b>. The elongate struts <b>236</b> that are not connected by circumferential connectors <b>228</b> are able to expand to a greater degree, providing for asymmetrical expansion about an apex in some embodiments. In this context, asymmetrical can refer to unequal movement upon expansion of the elongate struts <b>236</b> away from a central axis extending through an unexpanded apex. The central axis can be an axis intersecting an apex and being located equal distance from inner edges of unexpanded adjacent elongate struts <b>236</b>.

0060<figref idref="DRAWINGS">FIG. 4</figref> shows that while circumferential connectors <b>228</b> are provided in the impeller zone <b>212</b>, the connectors <b>228</b> can be omitted in the distal zone <b>208</b>. Such an arrangement provides enhanced rigidity of the impeller zone <b>212</b> compared to the distal zone <b>208</b>. <figref idref="DRAWINGS">FIGS. 6 and 14A-1 to 14A-3</figref> are other embodiments in which circumferential connectors <b>228</b> are provide throughout a distal zone as well as in an impeller zone. More generally, the circumferential connectors <b>228</b> can be provided between opposing sides of alternating adjacent elongate struts of less than all of the circumferential members in the distal zone <b>208</b>, while still providing benefits as discussed below. For example, a substantial portion such as one-half or more of the struts <b>236</b> can be connected by circumferential connectors <b>228</b> in the distal portion in one embodiment. In some embodiments, the density of connectors <b>228</b> in the distal zone <b>208</b> can be about one-half or less that in the impeller zone <b>212</b>.

0061In various embodiments, there can be different groups of circumferential connectors <b>228</b>. For example, in <figref idref="DRAWINGS">FIG. 4</figref> two groups of circumferential connectors <b>228</b>A, <b>228</b>B can be provided. A first plurality connectors <b>228</b>A can be provided about the impeller zone <b>212</b> in which the connectors have a length along the struts <b>236</b> that the connectors <b>228</b>A join that is greater than the separation between adjacent circumferential members, e.g. between the struts <b>236</b> that they join. The length of the connectors <b>228</b>A along the struts <b>236</b> that they join is greater than the separation between adjacent circumferential members in the unexpanded state in some embodiments. A second plurality connectors <b>228</b>B can be provided between the impeller an distal zones <b>212</b>, <b>208</b> in which the connectors have a length along the struts <b>236</b> that they join that is less than the length of the connectors <b>228</b>A. For example, the length of each of the connectors <b>228</b>B along the struts <b>236</b> to which they are coupled can be about one-half that of the first connectors <b>228</b>A. By providing longer connectors <b>228</b>A, enhanced stiffness can be provided in the impeller zone <b>212</b>. This can aid in collapsing the cannula, as discussed below. Longer connectors <b>228</b>A also contributes to dimensional stability of the impeller zone <b>212</b>, e.g., to minimize variance of a gap between a tip of an impeller and an inner surface of the cannula in the impeller zone <b>212</b>.

0062<figref idref="DRAWINGS">FIG. 4A</figref> shows details of a portion of the distal zone <b>208</b>. For example, a plurality of axial connectors <b>252</b> can be provided between proximal side of a proximal apex and a distal side of an adjacent circumferential member in the distal zone of the cannula. The same connectors can be provided in the impeller zone <b>212</b>. <figref idref="DRAWINGS">FIG. 4</figref> shows that in some embodiments a modified axial connector <b>252</b>A can be provided in the impeller zone <b>212</b>. The connectors <b>252</b>A have a first end that forms an apical connection with a proximally oriented apex <b>232</b>B and a second end. The second end is coupled in between adjacent apices of a circumferential member, e.g., along a side of an elongate strut <b>236</b>. The connectors <b>252</b>A can be connected to the struts <b>236</b> at the same location that the strut connects to an adjacent strut by way of the connector <b>228</b>A. The connectors <b>252</b>A are shortened compared to the connectors <b>252</b>. For example, they can extend with fewer undulations along their length, e.g., with a single inflection point between the ends.

0063In one embodiment, substantially all of the impeller zone <b>212</b> has enhanced rigidity connectors <b>252</b>A. <figref idref="DRAWINGS">FIG. 5</figref> shows a transition zone that can be provided at one or both of the proximal and distal ends of the impeller zone <b>212</b>. For example, a transition zone TZ-B can be provided to facilitate radial transition from the expanded size of the formed mesh to the diameter of a non-expanding portion <b>254</b> of the formed mesh that does not expand. A transition zone TZ-A between the impeller and distal zones can provide for more gradual change in mechanical characteristics to provide for gradual collapse of the cannula, as discussed below.

0064<figref idref="DRAWINGS">FIG. 5</figref> shows an expanded mesh structure <b>204</b> formed of the pattern <b>200</b>. The mesh structure <b>204</b> comprises a plurality of spaced apart helical zones <b>260</b>. The helical zones <b>260</b> are formed by adjacent struts <b>236</b> that have less or no movement relative to each other during expansion, where connectors <b>228</b> are provided. Adjacent struts that are connected by connectors <b>228</b> tend to move or expand less than struts that are not so connected, or do not move or expand at all. <figref idref="DRAWINGS">FIGS. 5 and 5A</figref> shows that the helical zones <b>260</b> are in the impeller zone <b>212</b> and not in the distal zone. The helical zones <b>260</b> provide enhanced concentration of material around the proximal apices <b>232</b>B of circumferential members <b>224</b> in the impeller zone <b>212</b>. Enhanced concentration of material provides enhanced local stiffness around the proximal apices <b>232</b>B, which provides greater stiffness and protects the proximal apices <b>232</b>B and connectors disposed thereon from fracture. As discussed more below in connection with <figref idref="DRAWINGS">FIG. 12</figref>, in some variants proximal apices in a zone (e.g., a distal zone) are omitted but the helical zones are induced to preserve this protective structure around the proximal apices. Such arrangements aid in the re-sheathing of a cannula incorporating this structure.

0065Enhanced concentration of material (e.g., increased struts per unit area) makes the connection between the apices <b>232</b>B and adjacent proximal circumferential member <b>224</b> more robust. In particular, larger forces are encountered in the impeller zone <b>212</b> during collapsing of, sometimes referred to as re-sheathing of, the cannula, e.g., after the catheter pump has been used.

0066<figref idref="DRAWINGS">FIG. 17</figref> shows a graph of axial force that may be required to be applied to an outer sheath, such as by the sheath assembly <b>88</b>, disposed about the catheter body <b>120</b> (see <figref idref="DRAWINGS">FIG. 2</figref>) as the sheath assembly is advanced distally along the cannula. This figure shows that in region A the force is relatively high when the distal end of the sheath initially engages the proximal end of the expanded zone of the cannula. The force also increases in a region B to a relatively high level when the distal end of the outer sheath is advanced to a location over the proximal end of the impeller. At each of these locations, the clinicians will note increased resistance to advancement of the sheath to collapse the impeller and/or the cannula and to draw the impeller and/or the cannula into the outer sheath, sometimes referred to herein as re-sheathing. From this graph, an increased risk of failure of one or more connections within the mesh of the cannula being tested has been discovered in these regions of local maxima. Surprisingly, however, various cannulae that have been tested have failed in the lower force region to the right of region B. As a result, there is a surprising benefit to be obtained in enhancing the robustness of the cannula in a region distal of the impeller zone. As discussed herein, the robustness can be enhanced in any one or all of a variety of ways, such as shortening axially oriented connectors between adjacent circumferential members, increasing material per unit area in a region around proximally oriented apices, providing an expanded configuration in which struts of the mesh are positioned close together around a weak point in the mesh structure, and other ways described herein.

0067<figref idref="DRAWINGS">FIGS. 4-5A</figref> and other embodiments herein illustrate some specific ways of improving the reliability of an expandable cannula, which can help to minimize the risk of breakage within the mesh, e.g., breakage of the connectors <b>252</b>A. A first technique is making the connectors <b>252</b>A shorter than the connectors <b>252</b>. A second technique involves the enhanced concentration of material around the proximal apices <b>232</b>B, discussed above.

0068The distal zone <b>208</b> is substantially free of the helical zones <b>260</b> or other concentration of material in the embodiment of <figref idref="DRAWINGS">FIG. 4-5A</figref>. In the distal zone <b>208</b>, the struts <b>236</b> expand substantially symmetrically about the apices <b>232</b>A forming a more uniform expanded mesh in the distal zone <b>208</b>. This arrangement enhances the overall flexibility of the distal zone <b>208</b>, which can be beneficial. Also, this arrangement makes local zones of the expanded mesh structure <b>204</b> substantially uniformly flexible. A mesh structure <b>204</b> with a more flexible distal zone <b>208</b>, and more uniform flexibility, can provide a cannula with a reduced risk of irritating the inner structures of the heart when deployed.

0069<figref idref="DRAWINGS">FIG. 6</figref> shows an embodiment, in which the distal zone <b>208</b> is modified to minimize a risk of fracturing connectors in the distal zone. For example, a first plurality of axial connectors <b>272</b> is disposed between a proximal side of a proximal apex <b>232</b>B and a distal side of an adjacent circumferential member <b>224</b> in the impeller zone <b>212</b>. <figref idref="DRAWINGS">FIG. 6A</figref> shows a second plurality of axial connectors <b>272</b>A is disposed between a proximal side of a proximal apex <b>232</b>B and a distal side of an adjacent circumferential member <b>224</b> in the distal zone <b>208</b> of the cannula. In the illustrated embodiment, connectors <b>272</b>A are provided between proximal apices <b>232</b>B and a middle portion of the elongate members <b>236</b>. The axial connectors <b>272</b>A of the second plurality have first and second ends, and a singe curved section therebetween. In contrast, the axial connectors <b>272</b> of the first plurality have first and second ends, and a plurality of curved section therebetween. Stated another way, the axial connectors <b>272</b> have multiple undulations and the connectors <b>272</b>A have a fewer undulation, e.g., a singe curved section.

0070Also, the distal zone <b>208</b> can be made less susceptible to fracture by providing circumferential connectors <b>228</b> in some embodiments. In the illustrated embodiment, every other elongate struts <b>236</b> of a circumferential member <b>224</b> in the distal zone <b>208</b> is connected to an adjacent elongate struts <b>236</b>.

0071<figref idref="DRAWINGS">FIGS. 7-7A</figref> show a cannula <b>296</b> incorporating the formed shape of a mesh with some features similar to those of the flat pattern of <figref idref="DRAWINGS">FIGS. 6 and 6A</figref>. In this embodiment the helical zones <b>260</b> are provided throughout the cannula <b>296</b>. In the embodiment of <figref idref="DRAWINGS">FIGS. 7-7A</figref>, apex-to-side connectors each have a plurality of undulations along their length, similar to the connectors <b>272</b>. However, providing side-to-side connectors <b>228</b> throughout the length of the cannula <b>296</b> enhances the concentration of material around the apex-to-side connectors. As such, the load applied by the advancement of the sheath over the cannula is spread out over a greater area and a smaller load is concentrated in the apex-to-side connectors. These are examples of techniques for minimizing the chance of fracture of connectors similar to the connectors <b>272</b>, <b>272</b>A.

0072<figref idref="DRAWINGS">FIGS. 8 and 9</figref> illustrate an embodiment that is similar to that of <figref idref="DRAWINGS">FIGS. 6 and 7</figref>. <figref idref="DRAWINGS">FIGS. 8 and 9</figref> show a wall pattern <b>300</b> and a mesh structure <b>304</b> that is configured to provide a good compromise of fracture resistance and flexibility for interaction with heart tissue. The impeller zone <b>312</b> has a plurality of circumferential connectors <b>328</b> whereas the distal zone <b>308</b> is substantially free of circumferential connectors. This provides an impeller zone with spaced apart helical zones, as discussed above, and a distal zone with substantially symmetrical expansion about proximally and/or distally oriented apices thereof. By removing the circumferential connectors in the distal zone, the distal zone is made more flexible. Axial connectors <b>352</b> are provided throughout the pattern <b>300</b>, but the distal zone <b>308</b> is provided with axial connectors <b>352</b>A that are less subject to fracture. For example, the connectors <b>352</b>A can be limited to fewer undulations than in the connectors <b>352</b> in the impeller zone <b>312</b>, as discussed above.

0073<figref idref="DRAWINGS">FIGS. 10 and 11</figref> illustrate an embodiment that is similar to that of <figref idref="DRAWINGS">FIGS. 6 and 7</figref>. <figref idref="DRAWINGS">FIG. 10</figref> shows a wall pattern <b>400</b> that has a higher concentration of material in the impeller zone <b>412</b>. Higher concentration of material can be achieved by more tightly packing the apices of the undulating structure of the circumferential members. For example, an angle can be formed between adjacent elongate struts <b>436</b> disposed on opposite sides of each of the apices. The angle can be smaller in the embodiment of <figref idref="DRAWINGS">FIGS. 10 and 11</figref> compared to that of <figref idref="DRAWINGS">FIGS. 6 and 7</figref>. Also, in order to provide more flexibility compared to the pattern of <figref idref="DRAWINGS">FIGS. 6 and 7</figref>, the pattern of <figref idref="DRAWINGS">FIGS. 10 and 11</figref> omits circumferential connectors in the distal zone <b>408</b>.

0074One technique for minimizing fracture risk in the distal zone <b>408</b> is to configure the mesh structure <b>404</b> to produce helical zones <b>460</b> throughout the structure, including in the distal zone <b>408</b> where there area no circumferential connectors. This can be achieved by heat setting the expanded shape in a material that would operate in an elastic range in this application. For example, nitinol can be configured to be compressed for delivery and heat set to expand to the shape seen in <figref idref="DRAWINGS">FIG. 11</figref>. This arrangement may provide good flexibility in the distal portion <b>408</b> and resistance to fracture of connectors between adjacent circumferential members <b>424</b>.

0075<figref idref="DRAWINGS">FIGS. 12-14</figref> illustrate an embodiment in which at least a distal zone is configured to be resistant to fracture. <figref idref="DRAWINGS">FIGS. 12 and 13</figref> show that in one embodiment, short connectors <b>452</b> are positioned in the distal zone. The short connectors <b>452</b> can be similar to those discussed above, e.g. having only a single curve or inflection between ends thereof. In one configuration, the short connectors <b>452</b> can have a length that is no more than about ten times the thickness of the outer sheath used to collapse the cannula. For example, these connectors can be about 0.035 inches long or less. The connectors <b>452</b> can be robust in their own right to permit a symmetrical expanded configuration for the distal zone of the wall pattern. Symmetrically expanded apices can provide some advantages, e.g., providing more uniform flexibility with the mesh structure, as discussed above. In some embodiments another technique can be used to spread a load applied by an outer sheath to the cannula incorporating the mesh illustrated in these figures. By spreading the load, the mesh is less subject to fracture.

0076The pattern arrangements in <figref idref="DRAWINGS">FIGS. 10-14</figref> also reduce stress and strain on the connectors by subjecting them to more pulling and less twisting during expansion and collapse of the mesh structure. Another advantage of these designs is that they tend to deflect the proximally oriented apices radially inward as the sheath approaches the proximally oriented apices so that a distal face of the sheath does not become lodged beneath the proximally oriented apices. In the heat set distal portion illustrated in <figref idref="DRAWINGS">FIG. 14</figref>, each connector <b>452</b> is disposed distal of a portion of an elongate strut <b>436</b>. The connectors <b>452</b> also can be located axially behind the elongate struts <b>436</b>. In contrast, in the embodiment of <figref idref="DRAWINGS">FIG. 13</figref>, the connector <b>452</b> is disposed distal of the nearest proximally oriented apex. The elongate struts <b>436</b> in the <figref idref="DRAWINGS">FIG. 14</figref> embodiment, helps guide the approaching outer sheath over the top of the proximally oriented apices. The elongate struts <b>436</b> also locally deflect the cannula in a zone between the connectors <b>452</b> and the outer sheath as the sheath approaches individual connectors to minimize any tendency of the connectors <b>452</b> deforming around the distal end of the sheath and later breaking.

0077Another approach to easing re-sheathing involves reducing an amount of open area in the formed cannula wall pattern around relative stiff proximally oriented structures. For example, the axially oriented undulating connectors in <figref idref="DRAWINGS">FIG. 5A</figref> may be more prone to fracture. At least two factors contribute to this. First, these connectors are relatively long. Also, they are surrounded on both sides by large areas not spanned by struts of the mesh pattern. These areas are covered with a polymer material to enclose a cannula. However upon re-sheathing this polymer material can ride over the outer surface of the outer sheath causing the proximal apices to ride over the outside of the sheath. This can lead to breakage of the axially oriented undulating connectors in <figref idref="DRAWINGS">FIG. 5A</figref>. This is input because the axially oriented connectors are relatively thin in at least one cross-sectional dimension and are formed of somewhat ductile metal. <figref idref="DRAWINGS">FIG. 13</figref> shows the connectors <b>452</b> shortened to minimize this effect. <figref idref="DRAWINGS">FIG. 14</figref> shows an embodiment in which more struts are placed around at least one side of the short connectors <b>452</b> in the helical zones <b>460</b>. Additionally, circumferential connectors can be provided in the distal zone for this purpose, as discussed herein.

0078<figref idref="DRAWINGS">FIG. 14A-1 to 14A-3</figref> show a proximal portion <b>462</b>A, a central portion <b>462</b>B, and a distal portion <b>462</b>C of a wall pattern <b>462</b>. Each of the portions <b>462</b>A, B, C has a plurality of circumferential members <b>466</b> in a relatively high metal density structure. The circumferential members <b>466</b> are close to each other in each of these portions. The members <b>466</b> have undulating configurations, e.g., with peaks and valleys. The peaks and valleys of neighboring members <b>466</b> can be received within each other, as shown in the figures. The proximal portion <b>462</b>A is configured to enhance structural integrity of the wall surrounding the impeller. Advantages for this arrangement are discussed above, and include minimizing variation in the gap between the tip of the impeller and the inner wall of the cannula into which the pattern of <figref idref="DRAWINGS">FIGS. 14A-1 to 14A-3</figref> is incorporated. In the illustrated embodiment, the stiffness of the proximal portion <b>462</b>A is enhanced by providing a plurality of elongate circumferential connectors <b>470</b>. The advantages of this sort of connector are discussed above, and include minimizing expansion of elongate struts <b>474</b> which are coupled by the connectors <b>470</b>.

0079As shown in <figref idref="DRAWINGS">FIG. 7</figref> an expanded cannula with connectors <b>470</b> will have an expanded configuration including spaced apart helical spines that arise from the minimal to no displacement of the struts <b>474</b> that are connected by the connectors <b>470</b>. The spines or other configurations including a connector <b>470</b> and a plurality of struts connected thereby advantageously provide areas of enhanced stiffness and/or strength in the wall of a cannula having the pattern <b>462</b>. Such regions can support an outward load without significant deflection. One outward load that can arise in operation is due to the fluid flowing in the cannula. Although the impeller is configured to primarily drive the blood axially the rotational movement may push blood into the inside wall of the cannula. The spines or other areas of enhanced stiffness can minimize deflection due to this load. Another outward load can be applied by a distal bearing structure such as that described in concurrently filed application Ser. No. 13/802,556 (now issued as U.S. Pat. No. 9,446,179), entitled “DISTAL BEARING SUPPORT,” filed on the same date as this application, which is hereby incorporated herein by reference in its entirety.

0080In addition to the connectors <b>470</b>, <b>470</b>A, the pattern <b>462</b> includes connectors <b>476</b> disposed between proximal oriented apices (or valleys, if the pattern is held distal end up) and distal edge of a circumferential member disposed proximally of the apex. The connectors <b>476</b> are relatively slender in order to permit the apices to which they are connected to flex upon expansion and collapse of the cannula into which the wall pattern <b>462</b> is incorporated. The proximal portion <b>462</b>A also provides enhanced concentration of material around the connectors <b>476</b> to minimize a chance of fracturing these connectors upon expansion and collapse of the cannula.

0081<figref idref="DRAWINGS">FIG. 14A-1</figref> illustrates a pattern in the proximal portion <b>462</b>A providing a high metal density cannula. The pattern has an embedded ring structure, which provides a first ring with a vertex of at least one adjacent ring within the axial length of the first ring. <figref idref="DRAWINGS">FIG. 14A-1</figref> illustrates embodiments where there are 2 or more adjacent vertices within the axial length of the first ring. There are several benefits of the embedded design for the pump <b>10</b>. The embedded design provides additional radial strength by increasing the number of load bearing rings per length of cannula. The embedded design minimizes the unsupported film area, which decreases the amount the film can flex as the pressure pulses generated by the impeller pass under it.

0082Other methods can be used to provide some of these benefits, include making the axial length of the rings shorter and increasing the number of sinusoidal waves within a ring. These features will result in other changes to the cannula pattern. Shorter rings tend to increase the strain the material must undergo in changing from the collapsed to expanded state. Suitable materials, such as nitinol, may be more prone to permanent deformation or fracture with increasing strain. Increasing the number of sinusoidal waves within a ring increases the diameter of the collapsed cannula, if other relevant factors (such as strut width) remains the same, may reduce the stress and strain to which the struts are subjected.

0083Other cannula patterns can be provided to reduce unsupported film area without increasing the number of embedded rings. For example, an arm feature could be added between two struts of adjacent rings. As the cannula transforms from the collapsed to expanded form, the arm orientation moves from a more axial to more radial orientation (in some cases, forming an “A” shape). More details of these structures are set forth in connection with <figref idref="DRAWINGS">FIGS. 15-16</figref> below.

0084In a transition zone between the proximal portion <b>462</b>A and the central portion <b>462</b>B, modified connectors <b>470</b>A are provided that are much shorter in a direction parallel to the longitudinal axis of the struts <b>474</b> than are the connectors <b>470</b>. The shorter connectors <b>470</b>A make the central portion <b>462</b>B much more flexible than the proximal portion <b>462</b>A. Such flexibility can provide less irritation to heart tissue and than higher biocompatibility as discussed elsewhere herein. <figref idref="DRAWINGS">FIG. 14</figref> shows that the connectors <b>470</b>A also are provided in the distal portion <b>462</b>C.

0085A proximal end of each of the connectors <b>476</b> is coupled to a portion of the strut <b>474</b> that is also connected to the connector <b>470</b> or <b>470</b>A. This structure provides a concentration of material around the more flexible and elongate connector <b>476</b> to minimize the chance of fracture of this structure when the cannula is collapsed by a sheath, as discussed herein. Because the sheathing forces are less in the distal portion of the cannula corresponding to the distal portion <b>462</b>C, the concentration of material in the distal portion <b>462</b>C around the connectors <b>476</b> can be less than in the proximal portion <b>462</b>A.

0086Various additional advantageous features are found on the proximal and distal portions <b>462</b>A, <b>472</b>C in various embodiments. For example, when the pattern <b>462</b> is formed a sheet-like zone <b>480</b> is provided that is advantageous for mechanically integrating the pattern <b>462</b> into various catheter bodies in an assembly. A plurality of cantilevered projections <b>482</b> is disposed in the sheet-like zone <b>480</b> and is disposed about the circumference of the proximal portion <b>462</b>A when the pattern <b>462</b> is formed into a tubular body. The projections <b>482</b> can be deflected into mating recesses in the catheter body <b>84</b> or another structure of a catheter assembly to provide a resistance to detachment of the pattern <b>462</b> (and the cannula into which it is incorporated) from the catheter body or assembly. Such resistance advantageously minimizes inadvertent separation of the cannula from the catheter body <b>84</b> during re-sheathing.

0087Also, the peak-to-peak distance between the proximal-most circumferential member <b>466</b> and the circumferential member immediately distal thereof is greater than the average peak-to-peak distance of adjacent circumferential members distal thereof. A consequence of this is that the connector <b>470</b> between the proximal-most circumferential member and the adjacent circumferential member is located closer to the peaks of the proximal most circumferential member. This creates an enlarged space <b>488</b> that aids in transitioning the diameter of the expanded cannula into which the pattern <b>462</b> is incorporated from a larger size disposed about the impeller to the diameter of the sheet-like zone <b>480</b> when formed into a tubular body.

0088The distal portion <b>462</b>C of the wall pattern includes elongate members <b>490</b> that are for mechanically integrating the pattern into a catheter assembly. The elongate members <b>490</b> extend from distal apices of the distal portion <b>462</b>C of the pattern <b>462</b>. The connectors <b>470</b>A and <b>476</b> disposed between the distal-most circumferential member <b>466</b> are shifted closer to the peak of the adjacent circumferential member <b>466</b> such that a larger space <b>492</b> is provided between the distal-most two circumferential members <b>466</b>. The shifting of these connectors provides a larger peak-to-peak distance between the distal-most two circumferential members <b>466</b> than is provided between other circumferential members of the pattern <b>462</b>. By increasing this distance, the transition from the enlarged diameter of the expanded cannula into which the pattern is incorporated to the smaller diameter of distally located non-expandable components of a catheter assembly can be facilitated.

0089<figref idref="DRAWINGS">FIGS. 15 and 15A</figref> illustrate another embodiment of a wall pattern <b>500</b> that can be combined any features of any of the wall patterns herein. These embodiments illustrate a proximal zone of the pattern that forms a transition zone between a non-expandable proximal portion <b>554</b> of a cannula and an impeller zone <b>512</b>. One feature of a cannula formed from the wall pattern <b>500</b> is the provision of a larger number of flow passages between inside of the proximal portion of the cannula and outside of the proximal portion thereof. A first outflow area is provided in one embodiment adjacent to the proximal end of the expandable portion of the cannula. In some embodiments, a second outflow area <b>520</b> is provided distal of the first outflow area. The first and second outflow areas <b>518</b>, <b>520</b> can take any suitable form. In the illustrated embodiment, the first outflow area is defined between a distal edge or side of a first circumferential member <b>524</b>A and a proximal edge or side of a second circumferential member <b>524</b>B.

0090<figref idref="DRAWINGS">FIG. 16</figref> shows the expanded configuration of one of a first plurality of openings <b>528</b>A formed in a mesh. Comparing <figref idref="DRAWINGS">FIGS. 15A and 16</figref> one can see that the plurality of openings can include four openings <b>528</b>A formed defined within the members <b>524</b>A, <b>524</b>B and connectors extending therebetween. The connectors can take any suitable form, such as those discussed above. In the illustrated embodiment, the second outflow area is defined between a distal side or edge of the second circumferential member <b>524</b>B and a proximal side or edge of a third circumferential member <b>524</b>C. More particularly, a plurality of openings <b>528</b>B in a mesh, e.g. four opening, formed by the pattern <b>500</b> are defined within the members <b>524</b>B, <b>524</b>C and connectors extending therebetween. The connectors can take any suitable form, such as those discussed above.

0091<figref idref="DRAWINGS">FIG. 16</figref> shows a cross-hatched zone distal of the openings <b>528</b>A, <b>528</b>B. The cross-hatched zone illustrates the area of the mesh structure that is covered to enclose the space within the mesh structure. Comparing <figref idref="DRAWINGS">FIG. 16</figref> with <figref idref="DRAWINGS">FIG. 9</figref>, one can appreciate that the openings <b>528</b>A are inclined with respect to the longitudinal axis of the spaced enclosed therein and the openings <b>528</b>B are less inclined and in some cases may be disposed on a substantially cylindrical surface about the longitudinal axis of the cannula. In this context, the concept of conforming to a cylindrical surface can be measured when the device is expanded but not implanted or in use. The mesh structure <b>500</b> should advantageously provide beneficial flow characteristics compared to an arrangement that only has flow openings <b>528</b>A. For example, by providing the flow openings <b>528</b>B (or other variant of a second outflow area <b>520</b>), the average flow velocity into or out of the cannula can be decreased. By decreasing the average flow velocity, stress on the blood cells can be reduced. Such stresses can be due to shear forces across the boundary into or out of the cannula. Lower stresses on red blood cells can lessen hemolysis or other harm to the blood.

0092<figref idref="DRAWINGS">FIGS. 15-16</figref> also illustrate the use of a circumferential connector <b>530</b> that is configured to reduce the extent of an unsupported portion of a structure enclosing a lumen within the mesh <b>500</b> after the mesh is formed into a cylinder. The connector has a proximal end <b>530</b>B coupled with a proximal circumferential member <b>524</b>B and a distal end <b>530</b>C coupled with a circumferential member <b>524</b>C that is located distal of the circumferential member <b>524</b>B. The length of the connector <b>530</b> is several times the unexpanded separation distance between the adjacent struts of the circumferential members <b>524</b>B, <b>524</b>C. The length of the connector <b>530</b> enables the adjacent struts of the circumferential members <b>524</b>B, <b>524</b>C to move away from each other to a much greater extent than permitted by the short circumferential connectors <b>470</b>. In the collapsed state, the connector <b>530</b> can be shaped to tightly nestle between the circumferential members <b>524</b>B, <b>524</b>C, for example, having a concave portion adapted to receive a portion of a crest of the circumferential members <b>524</b>B. In some embodiments, the connector <b>530</b> enables the adjacent struts of the circumferential members <b>524</b>B, <b>524</b>C to move away from each other to the same extent as if these struts were not connected by a circumferential member. See, for example, the struts of the circumferential members that are not connected by circumferential connectors in the expanded cannula shown in <figref idref="DRAWINGS">FIG. 7A</figref>. However, as can be seen in <figref idref="DRAWINGS">FIG. 16</figref>, the presence of the connector <b>530</b> greatly reduces the extent of the unsupported area between adjacent struts.

0093In one embodiment, the connector <b>530</b> is connected approximately in the middle of adjacent struts, e.g., half way between adjacent peaks and valleys on each circumferential member. This arrangement roughly reduced by 50 percent the unsupported area between these struts. Long slender struts may be more prone to shearing upon being collapsed into the sheath. Accordingly, it may be desirable to locate the struts <b>530</b> in areas of local minima of a sheathing force curve as discussed below in connection with <figref idref="DRAWINGS">FIG. 17</figref>. In other embodiments, the connectors <b>530</b> are located away from areas of local maxima of a sheathing force curve as discussed below in connection with <figref idref="DRAWINGS">FIG. 17</figref>.

0094<figref idref="DRAWINGS">FIGS. 5, 7, and 17</figref> illustrate further advantageous features of wall patterns. In particular, as noted above, a local maximum in the force-distance curve of <figref idref="DRAWINGS">FIG. 17</figref> is the region A, which corresponds to a transition zone between the non-expandable part of the mesh and the expandable impeller zone. The test illustrated in <figref idref="DRAWINGS">FIG. 17</figref> shows that this local maximum exceeds a threshold number that is based on clinician ease-of-use. On technique for reducing the level of this local maximum is to provide a shallower angle of the transition zone. In particular, an angle β can be provided between this inclined surface and a horizontal axis, e.g., an axis parallel to the undeflected longitudinal axis of the cannula. <figref idref="DRAWINGS">FIG. 7</figref> shows a smaller angle than that of <figref idref="DRAWINGS">FIG. 5</figref>. Preferably the angle β is within a range of from about 30 to about 40 degrees, in some embodiments not more than about 40 degrees. To reduce the force required for re-sheathing, the angle β can be maintained at about 30 degrees or less. The angle β may be maintained above a value that is a function of the trackability of the catheter assembly into which the mesh structure is incorporated. If the angle is too low, the length of the cannula or portions thereof may result in a too stiff cannula to properly track. Another advantage of the shallower angles suggested by <figref idref="DRAWINGS">FIGS. 7 and 17</figref> is that the impeller zone in a cannula incorporating this pattern is expected to be stiffer. This is one technique for providing better control of a gap between the impeller blade tip and the cannula wall. This tip gap control can advantageously minimize hemolysis and other damage to the blood, as well as any damage to the wall or blades that could be cause by impact therebetween.

0095The foregoing features of mesh patterns can be combined with other features for improving tip gap control. Such features can be incorporated into a distal bearing, as discussed in concurrently filed application Ser. No. 13/802,556 (now issued as U.S. Pat. No. 9,446,179), entitled “DISTAL BEARING SUPPORT,” filed on the same date as this application; and/or in impeller or impeller blade construction, as discussed in application Ser. No. 13/802,570 (now issued as U.S. Pat. No. 8,721,517), entitled “IMPELLER FOR CATHETER PUMP,” filed on the same date as this application. Both of these applications are incorporated by reference herein in their entirety.

0096Although the inventions herein have been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present inventions. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the present inventions as defined by the appended claims. Thus, it is intended that the present application cover the modifications and variations of these embodiments and their equivalents.